Endologix begins trial geared towards US cuff approval:
This article was originally published in Clinica
Executive Summary
Endologix, of Irvine, California, has started a multicentre, controlled investigational device exemption (IDE) trial intended to support US FDA approval of the large 34mm diameter Powerlink infrarenal cuff in conjunction with the firm's Powerlink product. Powerlink is a bifurcated endoluminal stent graft (ELG) approved by the FDA for the minimally-invasive treatment of abdominal aortic aneurysm (AAA). It is estimated that 35,000 ELG procedures will be performed in the US this year.
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